Coronary CT Angiography as the Primary Initial Method of Evaluating Patients With Subacute Chest Pain (CT PRIME)

Withdrawn before enrolling

Conditions studied: Coronary Artery Disease

In brief

This study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute chest pain patients in the out-patient setting. Patients in this study are selected to be "low-risk", meaning they are not having an acute or recent heart attack (AMI), based on screening blood tests and electrocardiograms (EKGs). In addition, these patients have a low or intermediate pre-test likelihood of the coronary artery disease (CAD), which means that probability of the CAD based on the available clinical and historical information, does not make a diagnosis of the CAD a certain clinical diagnosis in the particular patient and this, in turn, requires an additional diagnostic work up.

Key facts

Study ID

NCT00584337

Run by

Corewell Health East

People needed

0

Starts

2008-01-01

Expected to finish

2010-06-01

Last updated by the study team

2016-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-acute (onset≥72 hours) chest pain suggestive of possible underlying CAD in out-patient.
• Low or low-to-intermediate clinical likelihood of the CAD.
• Very low or low risk Goldman-Reilly risk group.
• Ability to provide informed consent.
• Age equal to or greater than 18 years.

You may not qualify if…

• Intermediate or higher risk of ACS by Goldman-Reilly criteria:
• Electrographic evidence of acute ST elevation myocardial infarction (STEMI) with ST segment elevation equal to or greater than 1mm in two or more contiguous leads).
• Electrocardiographic evidence of acute non-ST infarction (NSTEMI) or acute myocardial ischemia, including flat to down sloping ST segment depression equal to or greater than 1mm and/or T wave inversion equal to or greater than 2mm in 2 or more leads.
• Positive cardiac biomarkers (troponin and/or creatinine phosphokinase MB fraction) compatible with acute myocardial infarction on initial laboratory testing, based on the local laboratory upper range of normal.
• Clinical instability including cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg on therapy), sustained ventricular or atrial arrhythmia requiring intravenous medications.
• Presence of known pre-existing coronary artery disease (known prior myocardial infarction, EKG evidence compatible with prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
• Presence of signs or symptoms compatible with obvious non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
• Renal insufficiency (creatinine >1.5) or history of chronic or transient renal failure.
• Atrial fibrillation or other markedly irregular rhythm.
• Pregnancy or unknown pregnancy status.
• Known allergy to iodinated contrast.
• Inability to tolerate beta-blocking drugs, including patients with reactive airways disease requiring maintenance inhaled bronchodilators or steroids, complete heart block or second-degree atrioventricular block.
• Iodinated contrast administration within the past 48 hours.

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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